Events

Retiro De Equipo (Recall) de Dimension Vista Systems - Cyclosporine (CSA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Ltd Diagnostics Division.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-01297-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-05
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01297-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Siemens healthcare diagnostics has received complaints regarding variability in recovery of qc and patient results with the dimension vista csa flex reagent cartridge lots 12300bb, 12318bb, and 13011bb. investigation by siemens confirms that the performance of these lots are atypical, and internal testing observed increases of >25% over several days for cyclosporine results in samples with csa concentrations below 125 ng/ml. daily qc checks can detect performance variations in this assay.
  • Acción
    Siemens is advising users to discontinue use and discard remaining inventory. Siemens recommends that the communication is reviewed by the Laboratory Director, a review of previously generated results is at the discretion of the laboratory.

Device

Dimension Vista Systems - Cyclosporine (CSA) Flex reagent cartridge. An in vitro diagnostic medic...

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA